These are real people, with real stories - not just medical record numbers and case IDs. Lives are impacted forever by what we do, what we manufacture, and what we let into our operating rooms. I've processed instruments for thousands of patients up to this point, and led departments who have processed many thousand more - but I'm met with only a handful of patients, and never met with one who had a negative outcome such as an SSI or device complication. I know as a medical device reprocessing professional, it was powerful to hear and see these patient's stories. Speaking of cost, let's talk about how much $$ device manufactures make out of releasing "next generation" devices to replace existing devices in the field that are working just fine.Ģ) These stories of medical device failures must be told - because the device industry has zero incentive to tell it themselves. While innovation is still a positive force, the idolatrous worship of innovation is dangerous for our patients and our costly for our facilities. A surgeon in the film stated that innovation really means "untested," and again, that's true enough - considering that existing devices will always have more real-life evidence available regarding both the risks and rewards of the particular treatment or device. If there were one word that is the buzz word in this industry it is definitely "innovation," and I think this film did a great job at debunking the myth that innovation = good, safe, better. Agreements:ġ) Innovation is not the same thing as improvement. There is failure of the process all around. While there probably is blame due to the FDA, there should also be a level of responsibility on the part of individuals who contractually assumed that risk, and the physicians who led them there. Now, the argument could be made, and I think was carried this direction by the film, that patients and physicians unduly trust the FDA to be the informed part of that equation, leaving the consent part to be given by the patient. To my recollection, all of the surgeries and devices mentioned in the film related to elective procedures. No one forced these folks to use these devices. That being said, as is usual for many documentaries, I do not think the this film gave adequate attention to an important issue from the other side of the debate - informed consent. This is more a disagreement with the means rather than the message.ģ) I'm not an attorney (even though I punished myself by completing a year of law school in my younger days). But if your goal is to garner support from a watching world, then "F*CK Bayer" signs and decals of a kid peeing on the word "Essure" is probably not the best way to get there.
If Essure hurt you, you have every right to be angry and respond. But some of the language and methods they utilized to respond to these events, I felt, were misdirected. Regulation is not the silver-bullet.Ģ) A number of the individuals and groups interviewed for this documentary who were harmed by medical devices had real, heart-wrenching, harrowing stories (hence the aforementioned tears). If there is a system, it's going to be "gamed," if there's money to be made, it's going to be made. Obviously, that's not going to stop them from trying - but I think if we learned anything about the failure of FDA regulation and regulators from this film, it's that they deserve less power not more. What they failed to prove (and why I call it an assumption) is that the FDA or any governmental body can have the insight or wherewithal to properly, consistently, and 'without undue influence' regulate an industry like this. And as far as that goes, I'll grant that there are all kinds of holes in that process. The film makers spend a large portion of their time focusing on how easy it is to get a medical device to market through the 510K process and predicate device "loophole" (as they call it). But I've handled more medical devices in my short career than 90% of the folks in the brand new Netflix documentary "The Bleeding Edge", so this conversation is real for me - and if you're reading this, I'm sure it's just as real for you.ġ) There is a fundamental assumption in this film that regulation = safety. I've never been to an FDA meeting or gone through a 510K process. But then the anger set in, then fear, then a few tears as the reality of the current state of our medical device industry hit me like a ton of bricks.
Often it is used to describe the latest version of some technology or scientific undertaking.I should not have been as surprised as I was. Bleeding edge, also referred to as cutting edge, refers to a product, service, idea, or undertaking that is the newest in the market.
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